Efficacy and Safety of Early Initiation of Butylphthalide Treatment in Patients With Acute Ischemic Stroke.

Phase 2

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Behavioral: Butylphthalide treatment initiation time

• Registration Number: NCT06472921
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

This study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial designed to evaluate the difference in efficacy of Butylphthalide Sodium Chloride Injection treatment initiated early (\<3 hours) versus late (3-6 hours) in patients with acute ischemic stroke. The aim is to determine the optimal timing window for neuroprotective therapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Study Start: 2024-07-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age between 18 and 80 years, gender not specified;
2. Clinically diagnosed with acute ischemic stroke;
3. Stroke onset within 3 hours;
4. NIHSS score at enrollment between 4-25 points, with Item Ia ≤1 point;
5. Pre-stroke mRS score ≤1 point;
6. Participants and their representatives capable and willing to sign an informed consent form.

Exclusion Criteria

1. Confirmed intracranial hemorrhage within the past 3 months, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
2. Known severe hepatic or renal dysfunction or individuals undergoing dialysis for various reasons (severe hepatic dysfunction defined as ALT levels >3 times the upper limit of normal or AST levels >3 times the upper limit of normal; severe renal dysfunction defined as serum creatinine >3.0 mg/dl [265.2 μmol/L] or glomerular filtration rate [GFR] <30 ml/min/1.73m²);
3. Systolic blood pressure <90 mmHg or >220 mmHg;
4. Presence of bradycardia (heart rate below 60 beats per minute) or sick sinus syndrome;
5. History of drug or food allergies, including known allergies to the components of the study medication;
6. Treatment with medications containing Butylphthalide following the onset of the current stroke episode;
7. Congenital or acquired hemorrhagic disorders, coagulation factor deficiencies, thrombocytopenia, or similar conditions;
8. Pregnant or breastfeeding individuals, or those planning to become pregnant within the next 90 days;
9. Severe psychiatric disorders or dementia that preclude understanding of informed consent or compliance with follow-up procedures;
10. Concurrent malignancy or severe systemic disease with a life expectancy of less than 90 days;
11. Participation in another interventional clinical study within the last 30 days before randomization, or currently participating in another interventional clinical study;
12. Any other reason deemed by the investigator as unsuitable for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early initiation group	Butylphthalide treatment initiation time	Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days.
Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml	Butylphthalide treatment initiation time	Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days.

Primary Outcome Measures

Name	Time	Method
The proportion of participants with an mRS score of 0-2	90±7 days post-randomization

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with an improvement of ≥4 points in NIHSS scores	at 6±1 days and 12±2 days
Changes in NIHSS scores	at 6±1 days and 12±2 days compared to baseline
Proportion of participants with ineffective recanalization	at 90±7 days post-randomization
Difference in cerebral infarction volume size	between baseline and 12±2 days post-randomization
Proportion of participants with recurrent ischemic stroke	at 90±7 days post-randomization
Quality of life (EQ-5D) scores	at 90±7 days post-randomization
Proportion of participants with an mRS score of 0-1	90±7 days post-randomization
Early neurological deterioration	at 24±2 hours and 6±1 days post-randomization
Proportion of combined vascular events (recurrent stroke, myocardial infarction, and vascular death)	at 90±7 days post-randomization